Validation of RespiLife for Detection of Respiratory Suppression



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 80
Updated:4/6/2019
Start Date:December 20, 2018
End Date:March 20, 2019

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The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for
detection of respiratory rate and oxygen saturation in human subjects. This includes
evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and
oxygen saturation.

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for
detection of respiratory rate and oxygen saturation in human subjects. This includes
evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and
oxygen saturation.

Inclusion Criteria:

- Able to understand and sign the informed consent

- English speaking.

- Able to comply with visits and follow ups included in this protocol

- Ages 18-80 years

Exclusion Criteria:

- Mentally or cognitively incompetent persons who cannot understand the procedures or
consent to the procedures.

- An unstable medical condition, acute of chronic, that in the opinion of the
investigator puts the subject at health risks related this trial or interferes with
the clinical trial and data collection.

- If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to
the sleep study night. This will be determined ty the principal investigator based on
her judgment.

- Skin rash on the forehead.

- A history of skin allergy to medical tape, even hypoallergenic tape.

- A history of skin cancer on the forehead.
We found this trial at
1
site
Burlingame, California 94010
Principal Investigator: Deepti Sinha, MD
Phone: 650-779-4055
?
mi
from
Burlingame, CA
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